Systems and methods for making and using improved connectors for electrical stimulation systems

ABSTRACT

A connector for an implantable medical device includes a lumen extending from a port defined along a length of a connector housing. Axially-spaced-apart connector couplers are disposed along the lumen and are configured to couple to a proximal end of an inserted lead or lead extension. Each of the connector couplers includes a plurality of circumferentially-spaced-apart coupling members and at least one elastic member. The plurality of circumferentially-spaced-apart coupling members each have inner surfaces and outer surfaces. The inner surfaces of the coupling members are configured and arranged to couple to the proximal end of the lead or lead extension when the proximal end of the lead or lead extension is inserted into the lumen. The at least one elastic member couples the coupling members to one another such that a distance between the coupling members is expandable.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.13/430,270 filed Mar. 26, 2012, now allowed, which claims the benefitunder 35 U.S.C. §119(e) of U.S. Provisional Patent Application Ser. No.61/473,574 filed on Apr. 8, 2011, which is incorporated herein byreference.

FIELD

The present invention is directed to the area of implantable electricalstimulation systems and methods of making and using the systems. Thepresent invention is also directed to implantable electrical stimulationsystems having improved connector assembly designs, as well as methodsof making and using the connector assemblies and electrical stimulationsystems.

BACKGROUND

Implantable electrical stimulation systems have proven therapeutic in avariety of diseases and disorders. For example, spinal cord stimulationsystems have been used as a therapeutic modality for the treatment ofchronic pain syndromes. Peripheral nerve stimulation has been used totreat incontinence, as well as a number of other applications underinvestigation. Functional electrical stimulation systems have beenapplied to restore some functionality to paralyzed extremities in spinalcord injury patients.

Stimulators have been developed to provide therapy for a variety oftreatments. A stimulator can include a control module (with a pulsegenerator), one or more leads, and an array of stimulator electrodes oneach lead. The stimulator electrodes are in contact with or near thenerves, muscles, or other tissue to be stimulated. The pulse generatorin the control module generates electrical pulses that are delivered bythe electrodes to body tissue.

BRIEF SUMMARY

In one embodiment, a connector for an implantable medical deviceincludes an elongated connector housing having a first end, a secondend, and a length. The connector housing defines a port at the secondend of the connector housing. The port is configured and arranged forreceiving a proximal end of a lead or lead extension. A lumen extendsfrom the port along at least a portion of the length of the connectorhousing. A plurality of axially-spaced-apart connector couplers aredisposed along the lumen such that the connector couplers are eachexposed within the lumen. The connector couplers are configured andarranged for coupling to a proximal end of a lead or lead extension whenthe proximal end of the lead or lead extension is inserted into thelumen. Each of the connector couplers includes a plurality ofcircumferentially-spaced-apart coupling members and at least one elasticmember. The plurality of circumferentially-spaced-apart coupling memberseach have inner surfaces and outer surfaces. The inner surfaces of thecoupling members are configured and arranged to couple to the proximalend of the lead or lead extension when the proximal end of the lead orlead extension is inserted into the lumen. The at least one elasticmember couples the coupling members to one another such that a distancebetween the coupling members is expandable.

In another embodiment, a connector for an implantable medical deviceincludes an elongated connector housing having a first end, a secondend, and a length. The connector housing defines a port at the secondend of the connector housing. The port is configured and arranged forreceiving a proximal end of a lead or lead extension. A lumen extendsfrom the port along at least a portion of the length of the connectorhousing. A plurality of axially-spaced-apart, substantially-cylindricalconnector contact housings are disposed along the lumen. The pluralityof connector contact housings each have an inner diameter and an outerdiameter. For each connector contact housing the inner diameter forms aportion of a wall of the lumen. A plurality of spherically-shapedconnector contacts are disposed on or in each of the connector contacthousings such that at least a portion of each of the connector contactsextends into the lumen. For each connector contact housing each of theplurality of connector contacts are configured and arranged for couplingto a different single terminal disposed on a proximal end of a lead orlead extension when the proximal end of the lead or lead extension isinserted into the lumen.

BRIEF DESCRIPTION OF THE DRAWINGS

Non-limiting and non-exhaustive embodiments of the present invention aredescribed with reference to the following drawings. In the drawings,like reference numerals refer to like parts throughout the variousfigures unless otherwise specified.

For a better understanding of the present invention, reference will bemade to the following Detailed Description, which is to be read inassociation with the accompanying drawings, wherein:

FIG. 1 is a schematic view of one embodiment of an electricalstimulation system that includes a paddle body coupled to a controlmodule via lead bodies, according to the invention;

FIG. 2 is a schematic view of another embodiment of an electricalstimulation system that includes a percutaneous lead body coupled to acontrol module via a lead body, according to the invention;

FIG. 3A is a schematic view of one embodiment of a plurality ofconnector assemblies disposed in the control module of FIG. 1, theconnector assemblies configured and arranged to receive the proximalportions of the lead bodies of FIG. 1, according to the invention;

FIG. 3B is a schematic view of one embodiment of a connector assemblydisposed in the control module of FIG. 2, the connector assemblyconfigured and arranged to receive the proximal portion of one of thelead body of FIG. 2, according to the invention;

FIG. 3C is a schematic view of one embodiment of a proximal portion ofthe lead body of FIG. 2, a lead extension with a lead extensionconnector assembly, and the control module of FIG. 2, the lead extensionconfigured and arranged to couple the lead body to the control module,according to the invention;

FIG. 4 is a schematic perspective view of one embodiment of the leadextension connector assembly of FIG. 3C; according to the invention;

FIG. 5A is a schematic top view of one embodiment of connector contactsdisposed on a connector contact housing suitable for use with theconnector assembly of FIG. 4, according to the invention;

FIG. 5B is a schematic perspective view of one embodiment of theconnector contact housing of FIG. 5A, according to the invention;

FIG. 5C is a schematic perspective cross-sectional view of oneembodiment of the connector contact housing of FIG. 5A without theconnector contacts of FIG. 5A, according to the invention;

FIG. 6 is a schematic perspective cross-sectional view of anotherembodiment of the connector contact housing of FIG. 5A without theconnector contacts of FIG. 5A, according to the invention;

FIG. 7 is a schematic perspective cross-sectional view of yet anotherembodiment of the connector contact housing of FIG. 5C with theconnector contacts of FIG. 5A, according to the invention;

FIG. 8A is a schematic perspective view of one embodiment of a connectorcoupler having coupling members coupled together by elastic members, theelastic members formed as coiled springs, according to the invention;

FIG. 8B is a schematic front view of one embodiment of the connectorcoupler of FIG. 8A, the connector coupler including elastic members in arelaxed state, according to the invention;

FIG. 8C is a schematic front view of one embodiment of the connectorcoupler of FIG. 8A, the connector coupler including elastic members inan expanded state, according to the invention;

FIG. 9A is a schematic perspective view of one embodiment of theconnector coupler of FIG. 8A configured and arranged for coupling to aproximal end of a lead or lead extension, the connector couplerincluding elastic members in a relaxed state, according to theinvention;

FIG. 9B is a schematic perspective view of one embodiment of theconnector coupler of FIG. 8A coupled to a proximal end of the lead orlead extension of FIG. 9A, the connector coupler including elasticmembers in an expanded state to receive the lead or lead extension,according to the invention;

FIG. 10 is a schematic perspective view of another embodiment of theconnector coupler of FIG. 8A, the connector coupler having an elasticmember formed as an elastic band, according to the invention;

FIG. 11 is a schematic perspective view of yet another embodiment of theconnector coupler of FIG. 8A, the connector coupler having couplingmembers coupled together by an elastic member formed as a sheathdisposed over the coupling members, according to the invention; and

FIG. 12 is a schematic overview of one embodiment of components of astimulation system, including an electronic subassembly disposed withina control module, according to the invention.

DETAILED DESCRIPTION

The present invention is directed to the area of implantable electricalstimulation systems and methods of making and using the systems. Thepresent invention is also directed to implantable electrical stimulationsystems having improved connector assembly designs, as well as methodsof making and using the connector assemblies and electrical stimulationsystems.

Suitable implantable electrical stimulation systems include, but are notlimited to, an electrode lead (“lead”) with one or more electrodesdisposed on a distal end of the lead and one or more terminals disposedon one or more proximal ends of the lead.

Leads include, for example, deep brain stimulation leads, percutaneousleads, paddle leads, and cuff leads. Examples of electrical stimulationsystems with leads are found in, for example, U.S. Pat. Nos. 6,181,969;6,516,227; 6,609,029; 6,609,032; 6,741,892; 7,244,150; 7,672,734;7,761,165; 7,949,395; 7,974,706; 8,175,710; 8,224,450; and 8,364,278;and U.S. Patent Application Publication No. 2007/0150036, all of whichare incorporated by reference.

Electrical stimulation systems can be used to stimulation patient tissuein many different regions of a patient's body and may include, forexample, spinal cord stimulation, peripheral nerve stimulation, deepbrain stimulation, and the like. In the case of deep brain stimulation,a lead may include stimulation electrodes, recording electrodes, or acombination of both. A practitioner may determine the position of thetarget neurons using the recording electrode(s) and then position thestimulation electrode(s) accordingly without removal of a recording leadand insertion of a stimulation lead. In some embodiments, the sameelectrodes can be used for both recording and stimulation. In someembodiments, separate leads can be used; one with recording electrodeswhich identify target neurons, and a second lead with stimulationelectrodes that replaces the first after target neuron identification. Alead may include recording electrodes spaced around the circumference ofthe lead to more precisely determine the position of the target neurons.In at least some embodiments, the lead is rotatable so that thestimulation electrodes can be aligned with the target neurons after theneurons have been located using the recording electrodes.

Deep brain stimulation devices and leads are described in the art. See,for instance, U.S. Pat. No. 7,809,446 (“Devices and Methods For BrainStimulation”), U.S. Patent Application Publication No. 2010/0076535 A1(“Leads With Non-Circular-Shaped Distal Ends For Brain StimulationSystems and Methods of Making and Using”), U.S. Patent ApplicationPublication 2007/0150036 A1 (“Stimulator Leads and Methods For LeadFabrication”), U.S. Patent Application Ser. No. 12/177,823 (“Lead WithTransition and Methods of Manufacture and Use”), U.S. Pat. No. 8,600,518(“Electrodes For Stimulation Leads and Methods of Manufacture and Use”),U.S. Pat. No. 8,473,061 (“Deep Brain Stimulation Current Steering withSplit Electrodes”), and U.S. Patent Application Publication No.2009/0187222. Each of these references is incorporated herein byreference in its respective entirety.

FIG. 1 illustrates schematically one embodiment of an electricalstimulation system 100. The electrical stimulation system includes acontrol module (e.g., a stimulator or pulse generator) 102, a paddlebody 104, and one or more lead bodies 106 coupling the control module102 to the paddle body 104. The paddle body 104 and the one or more leadbodies 106 form a lead. The paddle body 104 typically includes aplurality of electrodes 134 that form an array of electrodes 133. Thecontrol module 102 typically includes an electronic subassembly 110 andan optional power source 120 disposed in a sealed housing 114. In FIG.1, two lead bodies 106 are shown coupled to the control module 102.

The control module 102 typically includes one or more connectorassemblies 144 into which the proximal end of the one or more leadbodies 106 can be plugged to make an electrical connection via connectorcontact (e.g., 316 in FIG. 3A) disposed in the connector assembly 144and terminals (e.g., 310 in FIG. 3A) on each of the one or more leadbodies 106. The connector contacts are coupled to the electronicsubassembly 110 and the terminals are coupled to the electrodes 134. InFIG. 1, two connector assemblies 144 are shown.

The one or more connector assemblies 144 may be disposed in a header150.

The header 150 provides a protective covering over the one or moreconnector assemblies 144. The header 150 may be formed using anysuitable process including, for example, casting, molding (includinginjection molding), and the like. In addition, one or more leadextensions 324 (see FIG. 3C) can be disposed between the one or morelead bodies 106 and the control module 102 to extend the distancebetween the one or more lead bodies 106 and the control module 102.

It will be understood that the electrical stimulation system can includemore, fewer, or different components and can have a variety of differentconfigurations including those configurations disclosed in theelectrical stimulation system references cited herein. For example,instead of a paddle body 104, the electrodes 134 can be disposed in anarray at or near the distal end of a lead body 106′ forming apercutaneous lead, as illustrated in FIG. 2. The percutaneous lead maybe isodiametric along the length of the lead body 106″. The lead body106′ can be coupled with a control module 102′ with a single connectorassembly 144.

The electrical stimulation system or components of the electricalstimulation system, including one or more of the lead bodies 106, thecontrol module 102, and, in the case of a paddle lead, the paddle body104, are typically implanted into the body of a patient. The electricalstimulation system can be used for a variety of applications including,but not limited to, spinal cord stimulation, brain stimulation, neuralstimulation, muscle activation via stimulation of nerves innervatingmuscle, and the like.

The electrodes 134 can be formed using any conductive, biocompatiblematerial. Examples of suitable materials include metals, alloys,conductive polymers, conductive carbon, and the like, as well ascombinations thereof. In at least some embodiments, one or more of theelectrodes 134 are formed from one or more of: platinum, platinumiridium, palladium, titanium, or rhenium.

The number of electrodes 134 in the array of electrodes 133 may vary.For example, there can be two, three, four, five, six, seven, eight,nine, ten, eleven, twelve, thirteen, fourteen, fifteen, sixteen, or moreelectrodes 134. As will be recognized, other numbers of electrodes 134may also be used. In FIG. 1, sixteen electrodes 134 are shown. Theelectrodes 134 can be formed in any suitable shape including, forexample, round, oval, triangular, rectangular, pentagonal, hexagonal,heptagonal, octagonal, or the like.

The electrodes of the paddle body 104 or one or more lead bodies 106 aretypically disposed in, or separated by, a non-conductive, biocompatiblematerial including, for example, silicone, polyurethane, and the like orcombinations thereof.

The paddle body 104 and one or more lead bodies 106 may be formed in thedesired shape by any process including, for example, molding (includinginjection molding), casting, and the like. Electrodes and connectingwires can be disposed onto or within a paddle body either prior to orsubsequent to a molding or casting process. The non-conductive materialtypically extends from the distal end of the lead to the proximal end ofeach of the one or more lead bodies 106. The non-conductive,biocompatible material of the paddle body 104 and the one or more leadbodies 106 may be the same or different. The paddle body 104 and the oneor more lead bodies 106 may be a unitary structure or can be formed astwo separate structures that are permanently or detachably coupledtogether.

Terminals (e.g., 310 in FIG. 3A) are typically disposed at the proximalend of the one or more lead bodies 106 for connection to correspondingconductive contacts (e.g., 316 in FIG. 3A) in connector assemblies(e.g., 144 in FIG. 1) disposed on, for example, the control module 102(or to other devices, such as conductive contacts on a lead extension,an operating room cable, a splitter, an adaptor, or the like).

Conductive wires (not shown) extend from the terminals (e.g., 310 inFIG. 3A) to the electrodes 134. Typically, one or more electrodes 134are electrically coupled to a terminal (e.g., 310 in FIG. 3A). In someembodiments, each terminal (e.g., 310 in FIG. 3A) is only coupled to oneelectrode 134.

The conductive wires may be embedded in the non-conductive material ofthe lead or can be disposed in one or more lumens (not shown) extendingalong the lead. In some embodiments, there is an individual lumen foreach conductive wire. In other embodiments, two or more conductive wiresmay extend through a lumen. There may also be one or more lumens (notshown) that open at, or near, the proximal end of the lead, for example,for inserting a stylet rod to facilitate placement of the lead within abody of a patient. Additionally, there may also be one or more lumens(not shown) that open at, or near, the distal end of the lead, forexample, for infusion of drugs or medication into the site ofimplantation of the paddle body 104. The one or more lumens may,optionally, be flushed continually, or on a regular basis, with saline,epidural fluid, or the like. The one or more lumens can be permanentlyor removably sealable at the distal end.

As discussed above, the one or more lead bodies 106 may be coupled tothe one or more connector assemblies 144 disposed on the control module102. The control module 102 can include any suitable number of connectorassemblies 144 including, for example, two three, four, five, six,seven, eight, or more connector assemblies 144. It will be understoodthat other numbers of connector assemblies 144 may be used instead. InFIG. 1, each of the two lead bodies 106 includes eight terminals thatare shown coupled with eight conductive contacts disposed in a differentone of two different connector assemblies 144.

FIG. 3A is a schematic side view of one embodiment of a plurality ofconnector assemblies 144 disposed on the control module 102. In at leastsome embodiments, the control module 102 includes two connectorassemblies 144. In at least some embodiments, the control module 102includes four connector assemblies 144. In FIG. 3A, proximal ends 306 ofthe plurality of lead bodies 106 are shown configured and arranged forinsertion to the control module 102. FIG. 3B is a schematic side view ofone embodiment of a single connector assembly 144 disposed on thecontrol module 102′. In FIG. 3B, the proximal end 306 of the single leadbody 106′ is shown configured and arranged for insertion to the controlmodule 102′.

In FIGS. 3A and 3B, the one or more connector assemblies 144 aredisposed in the header 150. In at least some embodiments, the header 150defines one or more ports 304 into which the proximal end(s) 306 of theone or more lead bodies 106/106′ with terminals 310 can be inserted, asshown by directional arrows 312, in order to gain access to theconnector contacts disposed in the one or more connector assemblies 144.

The one or more connector assemblies 144 each include a connectorhousing 314 and a plurality of connector contacts 316 disposed therein.Typically, the connector housing 314 defines a port (not shown) thatprovides access to the plurality of connector contacts 316. In at leastsome embodiments, one or more of the connector assemblies 144 furtherincludes a retaining element 318 configured and arranged to fasten thecorresponding lead body 106/106′ to the connector assembly 144 when thelead body 106/106′ is inserted into the connector assembly 144 toprevent undesired detachment of the lead body 106/106′ from theconnector assembly 144. For example, the retaining element 318 mayinclude an aperture through which a fastener (e.g., a set screw, pin, orthe like) may be inserted and secured against an inserted lead body106/106′.

When the one or more lead bodies 106/106′ are inserted into the one ormore ports 304, the connector contacts 316 can be aligned with theterminals 310 disposed on the one or more lead bodies 106/106′ toelectrically couple the control module 102 to the electrodes (134 ofFIG. 1) disposed at a distal end of the one or more lead bodies 106.Examples of connector assemblies in control modules are found in, forexample, U.S. Pat. Nos. 7,244,150 and 8,224,450, which are incorporatedby reference.

In at least some embodiments, the electrical stimulation system includesone or more lead extensions. The one or more lead bodies 106/106′ can becoupled to one or more lead extensions which, in turn, are coupled tothe control module 102/102′. In FIG. 3C, a lead extension connectorassembly 322 is disposed on a lead extension 324. The lead extensionconnector assembly 322 is shown disposed at a distal end 326 of the leadextension 324. The lead extension connector assembly 322 includes aconnector housing 328. The connector housing 328 defines at least oneport 330 into which a proximal end 306 of the lead body 106′ withterminals 310 can be inserted, as shown by directional arrow 338.

The lead extension connector assembly 322 also includes a plurality ofconnector contact housings 340. At least one connector contact 316 isdisposed on, or in, each of the connector contact housings 340 suchthat, when the lead body 106′ is inserted into the port 330, theconnector contacts 316 can be aligned with the terminals 310 on the leadbody 106′ to electrically couple the lead extension 324 to theelectrodes (134 of FIG. 1) disposed at a distal end (not shown) of thelead body 106′. The lead extension connector assembly 322 may alsoinclude the retaining element 318 for retaining the lead body 106′ whenthe lead body 106′ is inserted into the port 330.

The proximal end of a lead extension can be similarly configured andarranged as a proximal end of a lead body. The lead extension 324 mayinclude a plurality of conductive wires (not shown) that electricallycouple the connector contacts to terminal on a proximal end 348 of thelead extension 324. The conductive wires disposed in the lead extension324 can be electrically coupled to a plurality of terminals (not shown)disposed on the proximal end 348 of the lead extension 324. In at leastsome embodiments, the proximal end 348 of the lead extension 324 isconfigured and arranged for insertion into a lead extension connectorassembly disposed in another lead extension. In other embodiments (asshown in FIG. 3C), the proximal end 348 of the lead extension 324 isconfigured and arranged for insertion into the connector assembly 144disposed on the control module 102′.

It will be understood that the control modules 102/102′ can receiveeither lead bodies 106/106′ or lead extensions 324. It will also beunderstood that the electrical stimulation system 100 can include aplurality of lead extensions 324. For example, each of the lead bodies106 shown in FIGS. 1 and 3A can, alternatively, be coupled to adifferent lead extension 324 which, in turn, are each coupled todifferent ports of a two-port control module, such as the control module102 of FIGS. 1 and 3A. In some cases, two or more lead extensions 324may be coupled together. In which case, the at least one port 330 mayreceive the proximal end of another lead extension 324.

Patient movement may eventually cause a lead or lead extension insertedinto a connector to loosen, or even disconnect, from the connectorassembly, thereby reducing, or even completely discontinuing, thetherapeutic effects of the electrical stimulation system. For example,loosening of the lead or lead extension within the connector assemblymay cause terminals of the lead or lead extension to become partially,or even fully, misaligned with connector contacts disposed in theconnector assembly. It may, therefore, be advantageous to form aconnector assembly such that an inserted lead or lead extension is morelikely to remain inserted into the connector assembly despite bending,twisting, and stretching caused by patient movement over time.

When a lead or lead extension is inserted into a conventional connectorassembly, there may not be any feedback provided to the medicalpractitioner for gauging the degree of insertion of the lead or leadextension into the port of the connector assembly. Consequently, a leador lead extension may be inserted into the connector assembly such thatthe lead or lead extension appears to be properly inserted, yetterminals of the lead or lead extension are, in fact, not fullycontacting conductive contacts of the connector assembly. In such cases,the connector assembly and the lead or lead extension may be more likelyto loosen or disconnect from one another over time. It may, therefore,be advantageous to form a connector assembly that enables a medicalpractitioner to more easily identify when a lead or lead extension isfully inserted into the connector assembly. It may further beadvantageous to form a connector assembly that enables a medicalpractitioner to identify when terminals of a lead or lead extension arealigned with connector contacts of the connector assembly as the lead orlead extension is inserted into the connector assembly. It may also beadvantageous to form a connector assembly with connector contacts thatincrease the likelihood of maintaining contact with terminals of aninserted lead or lead extension, despite small misalignments.

In the case of lead extension connector assemblies, it may also beuseful to provide the lead extension with a connector assembly having atransverse diameter that is smaller than conventional lead extensionconnector assemblies. It may also be useful to provide a lead extensionwith a contact housing that is isodiametric, or nearly isodiametric.

In the case of deep brain stimulation, lead extension connectors aretypically disposed over the patient's skull. In which case, patient skindisposed over conventional lead extensions (and in particular overconventional lead-extension connectors) may begin to erode due to thesize of connectors assembly extending outwards from the patient's skull,the tightness of skin over the connector, and the potential mobility(e.g., rotational, translational, or the like) of the conventional leadextensions relative to the patient during patient activity.Additionally, the mobility of conventional lead extensions relative topatient movement may also cause lead extension failure (e.g., electricaldisconnection). One technique that has previously been used for reducingthese adverse effects is to carve out portions of the patient's scalp orskull to form one or more recesses; position the connector assembly orone or more portions of the lead extension in the one or more recesses;and suture the connector or lead extension to surrounding periosteom orscalp tissue. Carving out one or more recesses, however, can be laborintensive and invasive.

As herein described, a connector assembly includes a plurality ofconnector contacts that improve alignment between the connector contactsand inserted terminals. The connector assemblies have reduced-profiletransverse diameters from conventional connector assemblies. Theconnector contacts are disposed on a connector contact unit.

The connector contact unit can include either a connector contacthousing or a connector coupler.

In some instances, the connector assembly may additionally include oneor more of the following: a strain relief arrangement, an end stop, oneor more windows through which a medical practitioner can view a portionof a lead or lead extension while inserted into a connector assembly, aretaining element, or one or more connector flanges. In the case ofconnector couplers, the connector coupler can be used to mechanicallycouple with an inserted lead or lead extension in addition to, or inlieu of, electrically coupling connector contacts with the inserted leador lead extension. For example, the connector coupler can be used as anend stop.

It will be understood that the connector assembly may be disposed inmany different locations including, for example, on lead extensions (seee.g., 322 of FIG. 3C), lead adapters, lead splitters, the connectorportion of control modules (see e.g., 144 of FIGS. 1-3B), or the like.In preferred embodiments, the connector assemblies are disposed on thedistal ends of lead extensions, as described in more detail below. Itwill be understood that, depending on the location of the connectorassembly, one or more components of the connector assembly may beomitted. For example, connector assemblies disposed on control modulestypically do not include strain relief arrangements.

FIG. 4 is a schematic perspective view of one embodiment of theconnector assembly 322. The connector assembly 322 has a first end 402,a second end 404, and a length 406, shown in FIG. 4A as a two-headedarrow. The connector assembly 322 includes the connector housing 328.The connector housing 328 defines a port 330 into which a proximal endof a lead or lead extension can be inserted. In alternate embodiments,the connector housing 328 includes two or more ports, each configuredand arranged to receive a portion of a lead, or a lead extension, orboth (see e.g., FIGS. 1 and 3A).

The port 330 opens into a lumen (512 in FIGS. 5A-5C) extending along atleast a portion of the length 406 of the connector assembly 322. Aplurality of connector contacts 316 are disposed in the lumen such thatthe connector contacts 316 are electrically coupleable with leads orlead extensions inserted into the port 330. The connector contacts aredisposed in connector contact units 430. In at least some embodiments,the connector contact units 430 include axially-spaced-apart connectorcontact housings, such as contact housing 340, disposed in the lumen. Inother embodiments (see e.g., FIGS. 8A-11), the connector contact units430 include connector couplers (802 in FIG. 8A) disposed in the lumen.

In some cases, material 408 may be disposed over at least a portion ofthe connector housing 328. Optionally, the material 408 may betransparent or translucent to form windows through which a practitionercan view one or more portions of the lead or lead extension when thelead or lead extension is inserted in the port 330. The material 408 canbe formed from any suitable biocompatible material (e.g., polycarbonate,or the like).

The connector assembly 322 may, optionally, include one or more strainrelief arrangements 412 disposed along at least one portion of theconnector assembly 322. The strain relief arrangement 412 is configuredand arranged to expand and contract along the length 406 to absorbstrain potentially placed on the connector assembly 322 by patientmovement. In some cases, the one or more strain relief arrangements 412can bend with respect to a longitudinal axis of the connector assembly322. In at least some embodiments, at least one of the one or morestrain relief arrangements 412 is disposed at the first end 402 of theconnector assembly 322. The strain relief arrangement 412, optionally,can be formed as a portion of the connector housing 328.

The connector assembly 322 may include an end stop 414 which, at leastin part, modulates insertion of the lead or lead extension into the port330. The end stop 414 can be disposed in the lumen of the connectorassembly 322 in proximity to the first end 402. The end stop 414 canprovide one or more surfaces upon which the inserted lead or leadextension contacts, when the lead or lead extension is fully insertedinto the port 330. In some cases, the end stop 414 can provide theproximal-most point of insertion for the lead or lead extension withinthe connector assembly 322.

In some cases, it may be useful to provide one or more anchoring units415 for anchoring the connector assembly 322 to patient tissue. Forexample, in the case where the connector assembly 322 is disposed on alead extension used for deep brain stimulation, one or more anchoringunits 415 may be coupled to one or more surfaces of the connectorassembly and be used to couple the connector assembly 322 to thepatient's skull (e.g., using one or more fasteners, such as bolts,screws, pins, or the like, that extend through the anchoring unit 415).The one or more anchoring units may stabilize the orientation of theconnector assembly 322, such as preventing the connector from rotatingabout a longitudinal length of the connector assembly 322.

At least some conventional connector assemblies are configured to beanchored to patient tissue by suturing the connector housing directly topatient tissue. Suturing a connector assembly directly to patient tissuecan potentially cause damage to a corresponding lead extension or lead.In some instances, the one or more anchoring units 415 provide a surfacefor securing the connector assembly to the patient without suturing theconnector housing directly to patient tissue.

One example of an anchoring unit 415 is a connector flange 416. One ormore connector flanges 416 can be disposed on any external surface ofthe connector assembly 322. In some cases, the connector flange 416extends tangentially from the connector assembly 322. The connectorflange 416 may define one or more connecting apertures 418 through whicha fastener (e.g., a screw, pin, suture, binding clip, or the like) maybe inserted and secured against patient tissue. Optionally, theconnector flange 416 may include a surface that is configured andarranged for promoting tissue ingrowth (e.g., via appropriately sizedand shaped recesses, or the like). The tissue ingrowth may facilitatesecuring of the anchoring unit 415 to patient tissue over theimplantable lifetime of the connector assembly 322.

In some cases, the connector assembly 322 includes the retaining element318, which is configured and arranged to retain the lead or leadextension within the connector assembly 322. The retaining element 318defines an aperture 420 through which a fastener (e.g., a set screw,pin, or the like) may be inserted and secured against an inserted leador lead extension. When the connector assembly 322 includes one or moreconnector flanges 416, it may be advantageous to configure the retainingelement 318 such that the aperture 420 extends parallel with at leastone of the connector flanges 416. Such an arrangement may reduce theprofile of the connector assembly 322 along an axis perpendicular to theaxis along which the aperture 420 and the connector flange 416 extend.This may be of a particular advantage when the connector assembly 322 isdisposed on a lead extension used for deep brain stimulation. In whichcase, the connector assembly 322 may facilitate a reduction of skinerosion by taking advantage of the anatomy of the region of implantationwhere, although the tightness of patient skin discourages the connectorassemblies from extending very far outward from the patient's skull,there is often ample space to extend the connector assemblies outwardalong the surface of the patient's skull.

Turning to FIG. 5A, in some cases the connector assembly 322 includesconnector contact housings. In which case, at least one connectorcontact (e.g., 316 in FIGS. 3A and 3B) is disposed on, or in, each ofthe connector contact housings (e.g., 340 in FIGS. 3C and 4). FIG. 5Athrough FIG. 7 illustrate several different embodiments of connectorcontacts disposed on or in connector contact housings.

FIG. 5A is a schematic front view of one embodiment of a connectorcontact housing 502. FIG. 5B is a schematic perspective view of theconnector contact housing 502. FIG. 5C is a schematic perspectivecross-sectional view of a portion of the connector contact housing 502.In this embodiment, the connector contact housing 502 is substantiallycylindrical with an inner diameter 504 and an outer diameter 506.

In some cases, the connector contact housing 502 includes multipleelements 508, 510 axially coupled together. The inner diameter 504 ofthe connector contact housing 502 defines a portion of a lumen 512. Asdiscussed above, with reference to FIG. 4, the lumen is continuous withthe port 330 and extends along at least a portion of the length 406 ofthe connector assembly 322.

A plurality of connector contacts 520 are disposed on or in theconnector contact housing 502 such that a portion of each connectorcontact 520 is exposed to the lumen 512. By exposing the connectorcontacts 520 to the lumen 512, the connector contacts 520 canelectrically couple with a terminal of a lead or lead extension when aterminal-containing end of the lead or lead extension is inserted intothe port 330. For each particular connector contact housing 502, theconnector contacts 520 each form a separate contact point between atleast one (in at least some embodiments, only one) terminal of theinserted lead or lead extension and the electrical subassembly (110 inFIG. 1). It may be advantageous to establish a plurality of contactpoints between a terminal and the connector assembly 332 to reduce therisk of electrical misalignment between the terminal and the connectorcontacts 520. The connector contacts 520 are electrically coupled to theelectrical subassembly (110 in FIG. 1). In some cases, each of theconnector contacts 520 may be electrically coupled to one another viaone or more conductive portions of the connector contact housing 502.

The connector contact housings 502 can be configured and arranged to becoupled together into a stack. In which case, the connector contacthousings 502 can be stacked such that for each connector contact housing502 the connector contacts 520 of that connector contact housing 502couple with a first terminal of an inserted lead or lead extension,while the connector contacts of another connector contact housing couplewith a second terminal, and so on.

In some instances, the connector contacts 520 are disposed in pockets526 that are defined in the connector contact housing 502 and that openalong the inner diameter 504. In at least some embodiments, each pocket526 is configured and arranged to receive and retain a single connectorcontact 520. In alternate embodiments, the pockets 526 are configuredand arranged to receive and retain a plurality of connector contacts 520(see e.g., FIG. 7). In some instances, at least a portion of the pockets526 is formed from a conductive material and makes an electricalconnection with one or more connector contacts 520. When the connectorcontact housing 502 includes multiple elements 508, 510, the pockets 526may be formed such that a portion of at least one of the pockets 526 isdefined in each of the elements 508, 510 such that, when the elements508, 510 are coupled together, partial pockets 526 on each of theelements 508, 510 collectively form a complete pocket 526.

The connector contacts 520 can be formed in any suitable shape. Inpreferred embodiments, the connector contacts 520 are spherical. Thepockets 526, optionally, can be formed to enable the connector contacts520 to retract (e.g., move radially outward with respect to the lumen512) upon contact with an inserted lead or lead extension. FIG. 5C showsan extended portion 450 of the pockets 526 that extends the pocket 526along a radial axis. In preferred embodiments, the connector contacts520 can retract enough to reduce the amount of force needed to insertthe lead or lead extension into the port 330, while still maintainingelectrical contact with the inserted lead or lead extension. Decreasingthe amount of force needed to insert the lead or lead extension mayreduce damage to the lead, lead extension, or connector assembly 502caused as a result of excessive force being applied to the lead or leadextension during insertion of the lead or lead extension into the port330.

In some cases, the pockets 526 are open to the outer diameter 506 of theconnector contact housing 502. In which case, the connector contacts 520may extend radially from the outer diameter 506 of the connector contacthousings 502. When the material 408 is disposed over at least a portionof the connector housing 328, the outermost portions of the connectorcontacts 520 may contact the material 408. The material 408 may haveelastic properties suitable for providing an inward radial force againstthe connector contacts 520 that may be used to maintain contact betweenthe connector contacts 520 and an inserted lead or lead extension.

Turning to FIG. 6, in alternate embodiments the pockets 526 do notextend to the outer diameter 506 of the connector contact housing 502.FIG. 6 is a schematic perspective cross-sectional view of one embodimentof the element 508 of the connector contact housing 502. In FIG. 6, thepockets 526 defined in the element 508 do not extend to the outerdiameter 506 of the connector contact housing 502. In which case, anoutward-most surface 602 along a radial axis can provide an inwardradial force against the connector contacts 520 (not shown in FIG. 6 forclarity of illustration) that may be used to maintain contact betweenthe connector contacts 520 and an inserted lead or lead extension.

Turning to FIG. 7, in alternate embodiments at least one of theconnector contact housings 502 is configured and arranged to receivemore than one connector contact 520. In at least some embodiments, theconnector contact housing 502 defines a single pocket 526 that containsa plurality of the connector contacts 520. FIG. 7 is a schematicperspective cross-sectional view of one embodiment of the element 508 ofthe connector contact housing 502. The connector contact housing 502defines a single pocket 526 configured and arranged to contain each ofthe connector contacts 520. Optionally, the connector contacts 520 maybe able to move freely within the pocket 526. When the connector contacthousing 502 includes multiple elements, 508, 510, the pocket 526 can bedefined in either element 508 or 510, or collectively in both elements508, 510 (as described above, with reference to FIGS. 5A-5C). Note thatthe embodiment of the connector contact housing 502 illustrated in FIG.7 includes a pocket 526 that is defined in both elements 508, 510.Element 510, however, is not shown in FIG. 7 for clarity ofillustration.

Turning now to FIG. 8A, in some cases connector contacts are disposed inconnector contact units formed as connector couplers. FIGS. 8A-11illustrate several different exemplary embodiments of connectorcouplers.

FIG. 8A is a schematic perspective view of one embodiment of connectorcontact unit 430 formed as a connector coupler 802. The connectorcoupler 802 includes a plurality of coupling members 804 a and 804 battached to one another by elastic members 806 a and 806 b. In FIG. 8,the connector coupler 802 is shown having two coupling members 804 a and804 b attached to one another on opposite ends by two elastic members806 a and 806 b. The connector coupler 802, however, can include anysuitable number of coupling members including, for example, two, three,four, five, six, or more coupling members. The connector coupler 802 caninclude any suitable number of elastic members including, for example,two, three, four, five, six, or more elastic members. The number ofcoupling members can be less than, equal to, or greater than the numberof elastic members.

The coupling members 804 a and 804 b include inner surfaces 810 andouter surfaces 812. In at least some embodiments, the inner surfaces 810form concave arcs. The outer surfaces 812 can be formed in any suitableshape. In at least some embodiments, the outer surfaces 812 are likewisearced. When the connector coupler 802 has two coupling members 804 a and804 b, the inner surfaces 810 may be formed as opposing C-shapes. Theinner surfaces 810 are configured and arranged to contact an outersurface of a lead or lead extension inserted into the port 330. In somecases, the inner surfaces 810 are configured and arranged to contact aterminal of an inserted lead or lead extension.

The connector coupler 802 can be used to couple with an inserted lead orlead extension either mechanically, electrically, or both. When amechanical connection is desired with an inserted lead or leadconnection, the inner surfaces 810 of the coupling members 804 a and 804b can be formed from either conductive or non-conductive, biocompatiblematerial(s) suitable for implantation. When an electrical connection isdesired with the inserted lead or lead extension, the connector contactscan be formed from the inner surfaces 810 of the coupling members 804and 804 b. In which case, the inner surfaces 810 are conductive.Alternately, connector contacts can be formed from one or moreconductive members (e.g., conductive beads, or the like) coupled to theinner surfaces 810. In which case, the inner surfaces 810 can be formedfrom either conductive or non-conductive, biocompatible material(s)suitable for implantation.

As mentioned above, the connector coupler 802 can be used tomechanically couple to an inserted lead or lead extension in additionto, or in lieu of, electrically coupling to the lead or lead extension.FIGS. 8A-11 illustrate embodiments of the connector coupler 802 for useas connector contacts. It will be understood that the connector coupler802 can also be used to establish a desired mechanical connection withan inserted lead in addition to, or in lieu of, an electricalconnection. For example, the connector coupler 802 can be used to formthe end stop 414 to modulate insertion of the lead or lead extensioninto the connector assembly 322.

In FIG. 8A, the elastic members 806 a and 806 b are shown as beingcoiled springs. Alternately, the elastic members 806 a and 806 b can beformed using any suitable elastic structure (e.g., one or more bands,cords, clips, sleeves, or the like) formed from any suitablebiocompatible material.

The elastic members 806 a and 806 b can be used to maintain a connectionbetween the coupling members 804 a and 804 b and an inserted lead orlead extension. FIG. 8B is a schematic front view of one embodiment ofthe connector coupler 802 with the elastic members 806 a and 806 b in arelaxed state. FIG. 8C is a schematic front view of one embodiment ofthe connector coupler 802 with the elastic members 806 a and 806 b in anexpanded state. In some instances, the elastic members 806 a and 806 bcan be formed such that the coupling members 804 a and 804 b are held inclose proximity to one another when in a relaxed state. It may beadvantageous for the elastic members to hold the coupling members inclose proximity to one another when in a relaxed state to potentiallyreduce the transverse profile of the connector assembly when a lead orlead extension is not disposed in the connector assembly 322. In atleast some embodiments, when the elastic members 806 a and 806 b are ina relaxed state, the distance between the coupling members 804 a and 804b is less than a diameter of the inserted lead or lead extension.

The force constant of the elastic members 806 a and 806 b can be used toadjust the amount of force needed to expand the elastic members 806 aand 806 b enough to be able to insert a lead or lead extension betweenthe inner surfaces 810 of the coupling members 804 a and 804 b. Once thelead or lead extension is inserted between the coupling members 804 aand 804 b, the force constant also controls how tightly the couplingmembers 804 a and 804 b remain coupled to the inserted lead or leadextension. Optionally, the amount of force needed to insert the lead orlead extension between the coupling members 804 a and 804 b can befurther adjusted by providing a chamfered surface 816 along at least aportion of one side of one of the inner surfaces 810 of the connectorcoupler 802 to reduce the amount of applied force needed to insert alead or lead extension between the coupling members 804 a and 804 b.

FIG. 9A is a schematic perspective view of one embodiment of theconnector coupler 802 positioned in proximity to a proximal end 902 of alead or lead extension 904. The elastic members 806 a and 806 b of theconnector coupler 802 are in relaxed states. FIG. 9B is a schematicperspective view of one embodiment of the connector coupler 802 disposedover a terminal 906 disposed on the proximal end 902 of the lead or leadextension 904. The elastic members 806 a and 806 b of the connectorcoupler 802 are in expanded states to receive the terminal 906 of thelead or lead extension 904.

In preferred embodiments, the elastic members 806 a and 806 b have forceconstants that are low enough to enable insertion of the lead or leadextension 902 between the coupling members 804 a and 804 b, yet highenough to remain coupled to the received terminal 906.

Turning to FIG. 10, in alternate embodiments the elastic members 806 aand 806 b are formed using other elastic structures in lieu of, or inaddition to, coiled springs. FIG. 10 is a schematic perspective view ofanother embodiment of the connector coupler 802. In FIG. 10, thecoupling members 804 a and 804 b are held together by one or moreelastic bands 1006. In some cases, one or more elastic bands 1006 can beextended around a circumference of the connector coupler 802. In whichcase, the outer surfaces 812 may define one or more grooves (not shown)along which portions of the one or more elastic bands 1006 may extend.In some cases, the one or more grooves can be sized to receive the oneor more elastic bands 1006 such that the one or more elastic bands 1006do not extend radially outward therefrom.

FIG. 11 is a schematic perspective view of yet another embodiment of theconnector coupler 802. In FIG. 11, the coupling members 804 a and 804 bare held together by an elastic sleeve 1106 extending around acircumference of the connector coupler 802. In some instances, theelastic sleeve 1106 is the material 408 disposed over at least a portionof the connector housing 328. In other instances, the elastic sleeve1106 is separate from the material 408 and is disposed (e.g., press fit,or the like) inside the material 408.

FIG. 12 is a schematic overview of one embodiment of components of anelectrical stimulation system 1200 including an electronic subassembly1210 disposed within a control module. It will be understood that theelectrical stimulation system can include more, fewer, or differentcomponents and can have a variety of different configurations includingthose configurations disclosed in the stimulator references citedherein.

Some of the components (for example, power source 1212, antenna 1218,receiver 1202, and processor 1204) of the electrical stimulation systemcan be positioned on one or more circuit boards or similar carrierswithin a sealed housing of an implantable pulse generator, if desired.Any power source 1212 can be used including, for example, a battery suchas a primary battery or a rechargeable battery.

Examples of other power sources include super capacitors, nuclear oratomic batteries, mechanical resonators, infrared collectors,thermally-powered energy sources, flexural powered energy sources,bioenergy power sources, fuel cells, bioelectric cells, osmotic pressurepumps, and the like including the power sources described in U.S. Pat.No. 7,437,193, incorporated herein by reference.

As another alternative, power can be supplied by an external powersource through inductive coupling via the optional antenna 1218 or asecondary antenna. The external power source can be in a device that ismounted on the skin of the user or in a unit that is provided near theuser on a permanent or periodic basis.

If the power source 1212 is a rechargeable battery, the battery may berecharged using the optional antenna 1218, if desired. Power can beprovided to the battery for recharging by inductively coupling thebattery through the antenna to a recharging unit 1216 external to theuser. Examples of such arrangements can be found in the referencesidentified above.

In one embodiment, electrical current is emitted by the electrodes 134on the paddle or lead body to stimulate nerve fibers, muscle fibers, orother body tissues near the electrical stimulation system. A processor1204 is generally included to control the timing and electricalcharacteristics of the electrical stimulation system. For example, theprocessor 1204 can, if desired, control one or more of the timing,frequency, strength, duration, and waveform of the pulses. In addition,the processor 1204 can select which electrodes can be used to providestimulation, if desired. In some embodiments, the processor 1204 mayselect which electrode(s) are cathodes and which electrode(s) areanodes. In some embodiments, the processor 1204 may be used to identifywhich electrodes provide the most useful stimulation of the desiredtissue.

Any processor can be used and can be as simple as an electronic devicethat, for example, produces pulses at a regular interval or theprocessor can be capable of receiving and interpreting instructions froman external programming unit 1208 that, for example, allows modificationof pulse characteristics. In the illustrated embodiment, the processor1204 is coupled to a receiver 1202 which, in turn, is coupled to theoptional antenna 1218. This allows the processor 1204 to receiveinstructions from an external source to, for example, direct the pulsecharacteristics and the selection of electrodes, if desired.

In one embodiment, the antenna 1218 is capable of receiving signals(e.g., RF signals) from an external telemetry unit 1206 which isprogrammed by a programming unit 1208. The programming unit 1208 can beexternal to, or part of, the telemetry unit 1206. The telemetry unit1206 can be a device that is worn on the skin of the user or can becarried by the user and can have a form similar to a pager, cellularphone, or remote control, if desired. As another alternative, thetelemetry unit 1206 may not be worn or carried by the user but may onlybe available at a home station or at a clinician's office. Theprogramming unit 1208 can be any unit that can provide information tothe telemetry unit 1206 for transmission to the electrical stimulationsystem 1200. The programming unit 1208 can be part of the telemetry unit1206 or can provide signals or information to the telemetry unit 1206via a wireless or wired connection. One example of a suitableprogramming unit is a computer operated by the user or clinician to sendsignals to the telemetry unit 1206.

The signals sent to the processor 1204 via the antenna 1218 and receiver1202 can be used to modify or otherwise direct the operation of theelectrical stimulation system. For example, the signals may be used tomodify the pulses of the electrical stimulation system such as modifyingone or more of pulse duration, pulse frequency, pulse waveform, andpulse strength. The signals may also direct the electrical stimulationsystem 1200 to cease operation, to start operation, to start chargingthe battery, or to stop charging the battery. In other embodiments, thestimulation system does not include an antenna 1218 or receiver 1202 andthe processor 1204 operates as programmed.

Optionally, the electrical stimulation system 1200 may include atransmitter (not shown) coupled to the processor 1204 and the antenna1218 for transmitting signals back to the telemetry unit 1206 or anotherunit capable of receiving the signals. For example, the electricalstimulation system 1200 may transmit signals indicating whether theelectrical stimulation system 1200 is operating properly or not orindicating when the battery needs to be charged or the level of chargeremaining in the battery. The processor 1204 may also be capable oftransmitting information about the pulse characteristics so that a useror clinician can determine or verify the characteristics.

The above specification, examples and data provide a description of themanufacture and use of the composition of the invention. Since manyembodiments of the invention can be made without departing from thespirit and scope of the invention, the invention also resides in theclaims hereinafter appended.

What is claimed as new and desired to be protected by Letters Patent ofthe United States is:
 1. A connector for an implantable medical device,the connector comprising: an elongated connector housing having a firstend, a second end, and a length, the connector housing defining a portat the second end of the connector housing, the port configured andarranged for receiving a proximal end portion of a lead or leadextension; a lumen that extends from the port along at least a portionof the length of the connector housing; a plurality of axiallyspaced-apart, substantially-cylindrical connector-contact housingsdisposed along the lumen, the plurality of connector-contact housingseach having an inner diameter and an outer diameter, wherein for eachconnector-contact housing the inner diameter of that connector-contacthousing forms a portion of a wall of the lumen; and a plurality ofspherically-shaped connector contacts disposed on or in each of theplurality of connector-contact housings with at least a portion of eachof the plurality of connector contacts extending into the lumen, whereinfor each connector-contact housing each of the plurality of connectorcontacts disposed on or in that connector-contact housing is configuredand arranged for coupling to a different single terminal disposed on aproximal end portion of a lead or lead extension when the proximal endportion of the lead or lead extension is inserted into the lumen.
 2. Theconnector of claim 1, wherein at least one of the plurality ofconnector-contact housings defines at least one pocket configured andarranged for receiving at least one connector contact of the pluralityof connector contacts.
 3. The connector of claim 2, wherein the at leastone connector-contact housing that defines the at least one pocketcomprises a plurality of connector-contact-housing members coupledtogether with each of the plurality of connector-contact-housing membersforming a different portion of the at least one pocket.
 4. The connectorof claim 2, wherein the at least one pocket is configured and arrangedfor receiving a single connector contact of the plurality of connectorcontacts.
 5. The connector of claim 2, wherein the at least one pocketis configured and arranged for receiving at least two contacts of theplurality of connector contacts.
 6. The connector of claim 2, whereinthe at least one pocket comprises a surface that is at least partiallyformed from a conductive material.
 7. The connector of claim 2, whereinthe at least one pocket is open along the inner diameter of theconnector-contact housing.
 8. The connector of claim 2, wherein the atleast one pocket is open along the outer diameter of theconnector-contact housing.
 9. The connector of claim 8, furthercomprising elastic material disposed over the connector housing with theelastic material abutting the portion of the at least one pocket that isopen along the outer diameter of the connector-contact housing.
 10. Theconnector of claim 8, wherein the at least one pocket open along theouter diameter of the connector-contact housing is configured andarranged for receiving the at least one connector contact of theplurality of connector contacts with a portion of the least oneconnector contact extending outward from the at least one pocket beyondthe outer diameter of the connector-contact housing.
 11. The connectorof claim 1, wherein at least five connector contacts are disposed on orin at least one of the plurality of connector-contact housings.
 12. Theconnector of claim 1, further comprising a strain relief disposed alongthe first end of the connector housing.
 13. The connector of claim 1,further comprising an end stop disposed along the first end of theconnector housing.
 14. A connector assembly comprising: the connector ofclaim 1; and a lead configured and arranged for insertion into the lumenof the connector, the lead comprising a lead body with a proximal endportion and a distal end portion, a plurality of electrodes disposedalong the distal end portion of the lead body, a plurality of terminalsdisposed along the proximal end portion of the lead body, and aplurality of conductors electrically coupling the plurality ofelectrodes to the plurality of terminals.
 15. The connector of claim 14,further comprising at least one connector flange extending outwardlytangentially from an outer surface of the connector housing of theconnector, the at least one connector flange configured and arranged forproviding a surface for coupling the connector assembly to patienttissue.
 16. The connector of claim 15, further comprising a retainingelement for retaining the proximal end portion of the lead when theproximal end portion of the lead is inserted into the lumen, theretaining element defining an aperture configured and arranged toreceive a fastener for coupling to the inserted lead, wherein theaperture extends in a direction that is parallel to the at least oneconnector flange.
 17. The connector of claim 15, wherein the at leastone connector flange defines at least one connecting aperture extendingcompletely through the at least one connector flange, the at least oneconnector aperture configured and arranged for receiving a fastener. 18.The connector of claim 15, wherein the at least one connector flangecomprises at least one surface that defines at least one recessconfigured and arranged for promoting tissue ingrowth.
 19. An electricalstimulating system comprising: a lead comprising a lead body with aproximal end portion and a distal end portion, a plurality of electrodesdisposed along the distal end portion of the lead body, a plurality ofterminals disposed along the proximal end portion of the lead body, anda plurality of conductors electrically coupling the plurality ofelectrodes to the plurality of terminals; a control module electricallycoupled to the plurality of electrodes, the control module comprising ahousing, and an electronic subassembly disposed in the housing; a leadextension having a proximal end portion and a distal end portion,wherein the proximal end portion of the lead extension is coupleablewith the control module; and the connector of claim 1 disposed along thedistal end portion of the lead extension; wherein the proximal endportion of the lead is configured and arranged for insertion into theport of the connector.
 20. An electrical stimulating system comprising:a lead comprising a lead body with a proximal end portion and a distalend portion, a plurality of electrodes disposed along the distal endportion of the lead body, a plurality of terminals disposed along theproximal end portion of the lead body, and a plurality of conductorselectrically coupling the plurality of electrodes to the plurality ofterminals; a control module electrically coupled to the plurality ofelectrodes, the control module comprising a housing, and an electronicsubassembly disposed in the housing; and the connector of claim 1coupled to the housing of the control module; wherein the proximal endportion of the lead is configured and arranged for insertion into theport of the connector.